EOS imaging has received 510(k) clearance from the US Food and Drug Administration (FDA) for its new generation imaging system, EOSedge. Receipt of FDA 510(k) clearance follows the commercial launch of EOSedge in Europe, Canada and Australia last week.
EOSedge is the first general X-ray system powered by a high-resolution photon counting detector, delivering optimal image quality for outstanding musculoskeletal imaging exams.
EOSedge features Flex Dose technology to modulate radiation dose along the patient’s body, as well as an open cabin with a motorised, enlarged patient platform to facilitate easy and comfortable access for a broad range of patients to deliver larger fields of examination.
In a press release, EOS imaging said that EOSedge will strengthen its portfolio with the first-generation EOS system continuing to be part of the EOS imaging offering. Both EOSedge and the first-generation EOS system are designed to work with the Advanced Orthopedic Solutions, which include 3DServices, EOSapps 3D surgical planning for spine, hip and knee as well as EOSlink, which delivers the EOS surgical plan into the operating room to be used with advanced surgical technologies.